Phase 2
Completed N=81
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas
Source: ClinicalTrials.gov NCT00766467 ↗Enrolled (actual)
81
Serious AEs
9.9%
Results posted
Jul 2016
Primary outcomePrimary: Change From Baseline in Fatigue at Day 43 — -1; -3 units on a scale — p=0.3
Summary
The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also help to reduce radiation-induced fatigue in brain tumor patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Fatigue at Day 43 |
-1; -3 | 0.3 |
| SECONDARY Change From Baseline in Quality of Life at Days 22, 43 and 56 |
-1.76; -4.94; 2.50; -2.30; 1.83; -0.84 | — |
| SECONDARY Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment |
1; 0; 0; 1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Histologically confirmed malignant glioma including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma (WHO grade III/IV), glioblastoma multiforme (WHO grade IV) or gliosarcoma. Patients with a grade II astrocytoma, mixed oligo-astrocytoma or oligodendroglioma who are being treated with irradiation are also eligible
- Scheduled to receive irradiation to a total dose of 50-60 Gy. Patients receiving hyperfractionated radiotherapy are also eligible
- KPS of 70% or greater
- Electrolytes within normal institutional limits: BUN and Creatinine 28 on the Beck depression inventory consistent with severe depression
- Known hypersensitivity to armodafinil or related compounds
- Patients who have been receiving MAO inhibitors during the past 14 days
Data sourced from ClinicalTrials.gov (NCT00766467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.